FDA Quality Management System Requirements Proposal Becomes Final 

Hopefully by now the word of the FDA proposal to update the Quality System Regulations (QSR), otherwise known as 21 CFR 820, has made its way to everyone in the industry.  On February 23, 2022, the FDA released proposed changes to the QSR to align with ISO 13485:2016.  The proposed rule is known as the Quality Management System Requirements (QMSR).  

After going through a comment period, the rule became final on January 31, 2024. 

While the rule did not contain the final language to be incorporated into 21 CFR 820 or 21 CFR Part 4, it did contain information related to the changes that will be incorporated.  The rule will substantially change the current contents and structure of 21 CFR 820.  While the scope and definitions will remain, most of the remaining content will be withdrawn.  This is largely due to the similarities between most of 21 CFR 820 and ISO 13485:2016.  For sections with the same basic regulatory requirements, these items will be withdrawn and reference ISO 13485:2016.  

With this in mind, the remaining structure of the proposed 21 CFR 820 is significantly reduced.  Based on the proposed and final rule, the following structure is anticipated:

  • 820.1- Scope
  • 820.3 - Definitions
  • 820.7 - Incorporation by Reference
  • 820.10 – Requirements for a Quality Management System
  • 820.15 – Clarification of Concepts
  • 820.35 – Control of Records
  • 820.45 – Device Labeling and Packaging Controls

FDA has released information related to the content of these sections, which can be found here:

As seen in the download, the sections will reference any applicable ISO 13485:2016 clause (ex. 4.2.5, 7.5.1, etc.) and then add any FDA specific requirements.  For example, for 21 CFR 820.35, a reference to ISO 13485:2016 Clause 4.2.5 will be in place with the additional requirements:

  • Signature and date requirements for records
  • Information required by 21 CFR 803
  • UDI requirements
  • Confidentiality of records received by FDA

With the rule being final, the FDA can now focus its efforts on the necessary transition period.  The FDA has given a two-year period (February 2, 2026 due date) for medical device manufacturers and importers to implement the QMSR.  This will also give the FDA time to update the CFR and other applicable regulations, train inspectors to the new QMSR, update the Guide to Inspections of Quality Systems document (QSIT) or develop a new one, and basically prepare for life under the QMSR.  

All of this and many more questions can be viewed on the FDA website here:

The final rule with comments and answers can be viewed here:

Read our recent blog, Navigating 2024: An Overview of the Upcoming Initiatives from FDA impacting Medical Device and IVD Manufacturers, to learn more about upcoming FDA initiatives. 

If you have any questions or require any assistance with preparation and implementation of the QMSR, contact Qserve today.

Tim Joiner, MSc
Post date: February 09, 2024
How can we help you? Contact us